Vanoxide®-HC (Rx Only)

(5% benzoyl peroxide, 0.5% hydrocortisone)

NDC 11086-032-01
Vanoxide®-HC treats acne with 5% benzoyl peroxide in a water-based vanishing lotion base and calms inflammation with 0.5% hydrocortisone. Vanoxide-HC also controls excess dryness with a water-based lotion vehicle.

Benzoyl peroxide may cause irritation and contact dermatitis. Please read the full prescribing information below.

For more information about Vanoxide-HC, call 1-800-533-SKIN.

Prescribing Information Description:
Each gram contains, as dispensed, 50 mg benzoyl peroxide, and 5 mg hydrocortisone, in a vehicle of purified water, calcium phosphate, propylene glycol, caprylic/capric triglyceride, propylene glycol monostearate, laneth-10 acetate, decyl oleate, polysorbate 20, cetyl alcohol, mineral oil, lanolin alcohol, sodium phosphate, sodium biphosphate, stearyl heptanoate, hydroxyethylcellulose, tetrasodium EDTA, edetic acid, propylparaben, methylparaben, vegetable oil, monoglyceride citrate, silica, simethicone, BPH, Sodium hydroxide, BHA, propyl gallate, FD&C colors.

The structural formula for benzoyl peroxide is:

The structural formula for hydrocortisone, chemically 11ß. 17. 21-trihydroxypregn-4-ene-3, 20-dione is:

Clinical Pharmacology: Benzoyl peroxide is an antibacterial agent shown to be effective against P. acnes. The antibacterial action of benzoyl peroxide is believed to be due to the release of active oxygen. Benzoyl peroxide has a desquamative effect which may contribute to its efficacy. Benzoyl peroxide has been shown to be absorbed by the skin where it is converted into benzoic acid. Topical steroids are primarily effective because of their anti-inflammatory and vasoconstriction actions.

Indications and Usage: Indicated for the topical treatment of acne vulgaris.

Contraindications: Vanoxide-HC Lotion is contraindicated in individuals having known sensitivity to benzoyl peroxide, hydrocortisone, or any other listed ingredients. Topical steroids are contraindicated in viral diseases of the skin.

Warnings: If itching, redness, swelling, or undue dryness occurs, discontinue use.

Precautions: For external use only. Keep away from the eyes and mucous membranes. If severe irritation develops, discontinue use and institute appropriate therapy.

Information for Patients: Vanoxide-HC may bleach hair or colored fabric. If excessive irritation or dryness should occur, patients should discontinue medication and consult a physician. Discard product after three months and obtain fresh material.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies have not been performed to evaluate carcinogenicity or effect on fertility. Pregnancy, Category C – Animal reproduction studies have not been conducted. It is not known whether Vanoxide-HC Lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Vanoxide-HC Lotion should be given to a pregnant woman only if clearly needed. Nursing Mothers – it is not known whether this drug is excreted in human milk, caution should be exercised when administered to a nursing woman. Pediatric Use – Safety and effectiveness in children under the age of 12 have not been established.

Adverse Reactions: Irritation and contact dermatitis are the most frequent side reactions to benzoyl peroxide. Although 0.5% hydrocortisone is considered safe, the following adverse reactions have been reported with topical corticosteroids, especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria.

Dosage and Administration: Shake well before using. Apply a thin film 1 to 3 times daily gently massaging into skin, or as directed by physician. How Supplied and Dispensing Information: Bottles, 25 grams net weight as dispensed. Package contains a bottle of lotion base and a Benzoyl-Pak 3.8 g vial with benzoyl peroxide component.

To the Pharmacist – At the time of dispensing, add the contents of the Benzoyl-Pak to the lotion in the bottle. Shake well to ensure uniform dispersion. Place expiration date of three (3) months on the label. Vanoxide-HC Lotion (NDC 11086-032-01) is 25 g net weight. Caution: federal law prohibits dispensing without prescription.